BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study (278)

This study has been completed.
Sponsor:
Collaborators:
Lifespan
Rhode Island Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01744353
First received: November 26, 2012
Last updated: March 11, 2016
Last verified: March 2016
  Purpose

The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.

The experimental part of the study is combining these drugs together in FOLFOX-A.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Dose level 1
Drug: Dose level 2/MTD
Drug: Dose level 3
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. [ Time Frame: For up to 30 days post completing drug, an expected average of 6 months ] [ Designated as safety issue: Yes ]
    MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.


Secondary Outcome Measures:
  • Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer. [ Time Frame: pre-drug until disease progression, whichever comes first, for an expected average of 6 months ] [ Designated as safety issue: No ]
    Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters


Enrollment: 35
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose level 1
Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Drug: Dose level 1
Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
Experimental: Dose level 2/ MTD
Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Drug: Dose level 2/MTD
Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
Experimental: Dose level 3
Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Drug: Dose level 3
Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Detailed Description:
More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed pancreatic ductal adenocarcinoma.
  • Metastatic or locally advanced disease.
  • No prior treatment for pancreatic cancer
  • Radiographically measurable disease.
  • No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
  • Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  • Preexisting neuropathy > grade 1.
  • No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  • ECOG performance status 0 or 1.
  • Age ≥ 18 years of age.
  • Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
  • Required Initial Laboratory Values:

    • Neutrophils ≥ 1,500/μl
    • Platelet count ≥ 100,000/μl
    • Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
    • Total bilirubin ≤ 1.5 x ULN
    • AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN

Exclusion Criteria:

-Patients with known brain metastases

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744353

Locations
United States, Rhode Island
Memorial Hospital
Pawtucket, Rhode Island, United States, 02860
Rhode Island Hospital (including Newport and East Greenwich locations)
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Lifespan
Rhode Island Hospital
Memorial Hospital of Rhode Island
Investigators
Principal Investigator: Howard Safran, MD Brown University
  More Information

Responsible Party: howard safran, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01744353     History of Changes
Other Study ID Numbers: BrUOG 278 
Study First Received: November 26, 2012
Results First Received: May 6, 2015
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
newly diagnosed
advanced pancreatic cancer
pancreatic cancer
metastatic pancreatic cancer
pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Albumin-Bound Paclitaxel
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016